Trial Outcomes & Findings for Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery (NCT NCT02812186)
NCT ID: NCT02812186
Last Updated: 2020-04-08
Results Overview
To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
79 participants
Primary outcome timeframe
Intra-operative, from intubation time to extubation time
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
Deep to Moderate Neuromuscular Block (NMB)
This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.
Rocuronium
|
Moderate to Deep NMB
This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.
Rocuronium
|
|---|---|---|
|
Period 1
STARTED
|
40
|
39
|
|
Period 1
COMPLETED
|
29
|
24
|
|
Period 1
NOT COMPLETED
|
11
|
15
|
|
Period 2
STARTED
|
29
|
24
|
|
Period 2
COMPLETED
|
29
|
24
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Deep to Moderate Neuromuscular Block (NMB)
This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.
Rocuronium
|
Moderate to Deep NMB
This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.
Rocuronium
|
|---|---|---|
|
Period 1
Post randomization screen failure
|
5
|
9
|
|
Period 1
nonevaluable data sets
|
6
|
6
|
Baseline Characteristics
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
Baseline characteristics by cohort
| Measure |
Deep to Moderate NMB
n=29 Participants
This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.
|
Moderate to Deep NMB
n=24 Participants
This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 15.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Procedure
General
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Procedure
General/Gynecology
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Procedure
Gynecology
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Procedure
Urology
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-operative, from intubation time to extubation timeTo determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB
Outcome measures
| Measure |
Deep NMB
n=53 Participants
This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery
|
Moderate NMB
n=53 Participants
This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery
|
|---|---|---|
|
Peak Airway Pressures
Maximum
|
28 cm H2O
Interval 24.0 to 32.0
|
30 cm H2O
Interval 27.0 to 36.0
|
|
Peak Airway Pressures
Mean
|
25.5 cm H2O
Interval 23.6 to 30.3
|
28.3 cm H2O
Interval 23.9 to 35.0
|
SECONDARY outcome
Timeframe: Intra-operative, from intubation time to extubation timeTo compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB
Outcome measures
| Measure |
Deep NMB
n=53 Participants
This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery
|
Moderate NMB
n=53 Participants
This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery
|
|---|---|---|
|
Abdominal Insufflation Pressure
|
15 mmHg
Interval 14.8 to 15.2
|
15 mmHg
Interval 14.6 to 15.2
|
SECONDARY outcome
Timeframe: Intra-operative, from intubation time to extubation timeTo compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome.
Outcome measures
| Measure |
Deep NMB
n=53 Participants
This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery
|
Moderate NMB
n=53 Participants
This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery
|
|---|---|---|
|
Surgical Rating Scale
|
5 units on a scale
Interval 5.0 to 5.0
|
5 units on a scale
Interval 5.0 to 5.0
|
Adverse Events
Deep NMB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate NMB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place